My new book, "Health, Medicine and Justice: Designing a fair and equitable healthcare system", is out and and widely available!
Medicine and Social Justice will have periodic postings of my comments on issues related to, well, Medicine, and Social Justice, and Medicine and Social Justice. It will also look at Health, Workforce, health systems, and some national and global priorities

Sunday, September 27, 2015

“A
Huge Overnight Increase in a Drug’s Price Raises Protests”, by Andrew
Pollack in the New York Times September
20, 2015, features the story of Daraprim, the brand name for pyrimethamine, a
drug used to treat toxoplasmosis. “Toxo”, often associated with cat feces, is a
protozoan and was an fairly rare infection prior to the HIV epidemic, when it
became a significant cause of brain infections in those with very low CD4
counts. Luckily, pyrimethamine, a drug available for over 60 years, had
reasonably good success. Now, rights to the drug have been acquired by Turing
Pharmaceuticals and its price has been raised from $13.50 to $750 a pill.
Turing’s founder and CEO, Martin Shkreli, is a former hedge fund manager who
seems to know an opportunity to make a killing when he sees one. A few days
later, the Times ran an AP
story on a interview Shrkeli gave ABC news which reported that Turing would
reduce the price, albeit to one that was unspecified. “’We've agreed to lower the price of Daraprim to a
point that is more affordable and is able to allow the company to make a
profit, but a very small profit,’ Shkreli told ABC.”

But this is, as the Pollack article points out, not the
first or only time this has occurred. In the last few years new drugs, mainly
those made in labs from recombinant DNA rather than from plant sources, for
hepatitis C, high cholesterol, and various cancers have been criticized for
their astronomical prices, but we are talking about old drugs here. One example is cycloserine, used to treat
multi-drug resistant (MDR) TB, the price of which has been raised from the
previously expensive $500 for a month’s supply to $10,800. (Please note that I
am being careful with my decimal points; this is, indeed, over a 2000%
increase.) The general manager of the manufacturer, Rodelis, “…said the company
needed to invest to make sure the supply of the drug remained reliable.” And
thus, of course, required the 2000% increase. Right.

And many more common, prosaic drugs have had the same
increases. One I have previously written about several times is colchicine, an
ancient treatment for gout derived from the autumn crocus (and I mean
“ancient”, not like “20th century”; there are records of its use in Egyptian
papyruses from 1500BC!). Dr. Stephen Griffith’s guest post "VISA
and colchicine: maybe the banks and Pharma really ARE in it for the money!”
said ”the FDA has encouraged pharmaceutical companies to study some of the
older drugs for true effectiveness, and the company can then apply for a three
year patent on the medication. URL Pharma, Inc. did the clinical trials on less
than 1,000 patients, and proved that a drug everyone already knew worked,
worked. Amazing! They received a three year patent, and now a pill that was $4
per month long before the $4 per month plans existed, is $5 per pill! Since it
is usually given twice a day, the drug will now cost patients $10 per day when
it formerly cost about a quarter.” What? The FDA is encouraging this?

The Times articles
cites increases in other common drugs; two heart drugs, Nitropress and Isuprel,
were acquired by Marathon Pharmaceuticals in 2013 and had their prices
quintupled. Then this year, they were acquired by Valeant Pharmaceuticals which
“…promptly raised their prices by 525 percent and 212 percent respectively.”
The most depressing one for me is doxycycline, a form of the antibiotic
tetracycline, which is broad-spectrum, effective, and, until recently, cheap.
It is frequently used for pneumonia acquired in the community, as it is
effective against both common bacterial and “atypical” causes of pneumonia, and
generally effective against the very dangerous “methicillin-resistant
Staphylococcus aureus”, or MRSA. It is used as a first or second-line drug for
several sexually-transmitted infections (STIs), including syphilis, and is even
effective for prevention and treatment of malaria. An altogether good drug.
When I was a medical student, it had recently been introduced (under the brand
name Vibramycin) and it was considered expensive compared to other
tetracyclines, even if often more effective. So we were all very happy when it
became generic and cheap. Indeed, the Wikipedia entry for
doxycycline says “Doxycycline is
available as a generic medicine and is not very expensive.[1][5] The
wholesale cost is between 0.01 and 0.04 USD per pill.[6] In the
United States 10 days of treatment is about 14 USD”. Um, that seems to be dated. The Times article tells us that “Doxycycline,
an antibiotic, went from $20 a bottle in October 2013 to $1,849 by April 2014.” Oh. A 9200% increase. Kind of high for
treating your bronchitis, or even your outpatient (or inpatient) pneumonia, or
for your Lyme disease, or Chlamyida
vaginitis, or for taking malaria prophylaxis.
Maybe you wouldn’t be very happy to have to pay that when you pick up
your prescription, if you don’t have prescription drug coverage. And if you do,
I’m sure that your insurer is not. The issue of how this price increase was
allowed to happen is
described as “murky” by David Lazarus in the Los Angeles Times. [Note: it seems that some of the generic forms
of doxycycline have come back down, per a search on the valuable-for-health-care-providers-or-anyone-taking-prescriptions
app, Goodrx.]

These price increases for long-standing generic drugs are
outrageous, even more than the predatory prices of the new recombinant DNA
drugs. It is blatant opportunism on the part of the drug manufacturers
certainly, who could be considered to be cold-blooded profiteers on human
misery (which of course they are, not to say evil, immoral, unconscionable and
inhuman). But, hey, they are in business and are taking an opportunity to make
more money, as does every cold-blood, profiteering business, in what is apparently
a legal way. This, of course, raises the question of “how come it is legal?
What the heck happened?” Where is the
FDA? Where is the Department of Health and Human Services? Where is the
Executive Branch? Where is the Congress? Remember, we’re not talking small
price increases. We’re not talking fair pricing. We’re talking thousands of percent increases in common
drugs that people need, drugs that I, and other doctors, prescribe a lot.

People care a lot about the price of prescription drugs, and
the amount that their co-pay is, because this affects them directly, in their
pocketbook, regardless of what party they vote for. Margot Sanger-Katz of the Times, in “Prescription Drug Costs Are Rising as a
Campaign Issue”, reports on a Kaiser Family Foundation survey that
Americans identify costs for drugs for specific diseases and prescription drug
costs overall as their #1 and #2 health concerns. “Americans have long paid the
highest prices for drugs. Because the United States gives drug makers long
periods of patent exclusivity and lets a multitude of insurers each negotiate
with drugmakers on price, drug spending here is, on a per capita average,
roughly double the amount spent in many developed countries.” (see figure)

I started out saying that these companies were making a
killing, but the problem is that the ones being killed are the rest of us.
Sounds like something Jim Hightower would say, and he’d be right. The real
issue is why do we keep electing people who put our interests, our health,
behind the rapacious profits of corporations. It is only because of the
enormous coverage Turing’s increase in the price of Daraprim engendered, and
the calls for investigations in Congress, that Shrkeli is planning to lower the
price. It has nothing to do with his, or any other corporate leaders’, concern
for the public (see, for example: Volkswagen diesels, poisoned peanuts).

By the way, you might want to write down the names of the
two Congresspeople the Times article
notes have called for an investigation of this: Representative Elijah Cummings
of Maryland and Senator Bernard Sanders of Vermont. Yes, that Bernard Sanders;
the one running for President. Hmm.

Sunday, September 20, 2015

In an editorial on August 30, 2015, the New York Times discusses the “Battle
for Biomedical Supremacy”, looking at the practice of what they call
“poaching” of biomedical researchers by one state or university from another.
Their main focus on the receiving end is Texas, because it has the highest
profile of spending really big money
to recruit researchers from universities in other states, and its main concern
is (unsurprisingly) New York, which has more medical schools than any other
state, and especially private medical schools with big endowments and big
research programs to be “poached”. They raise the issue, but I am not (after
reading it a few times) quite sure what their position is and I am afraid that
they may not be either, since usually the position of the Times editorialist is clear. It seems to be saying “Well, New York
needs to join this, but not spend too much public money on it.” But the
editorial certainly does not condemn the practice.

I am not sure that I am wholly against it, either.
Biomedical research is important. Researchers who can get better jobs (higher
paying, more money to support their work) should not generally be criticized
for accepting them. People have that right. On the other hand, from the point
of view of the institutions that are being poached from, there can be not only feelings of sadness, betrayal, and
anger, but in many cases financial losses that result from money they spent to recruit these “top
researchers”, and now is down the drain, or so it seems. Sometimes these
researchers are signed to contracts, just as physicians who bring in lots of
money for a hospital are. These contracts for physicians may contain
“non-compete” agreements, which (try to) restrict the area in which a physician
leaving their employment can practice. They are more enforceable when they are
more local, preventing them from going over to direct competitors, but not when
someone is moving from NY to Texas. And the competition in biomedical research
is much more national than the competition for direct medical care. On the
other hand, if you hire mercenaries, you run the risk that someone will offer
them more.

So it can increase the income and resources for the
individual investigator (and his/her “team”) and can increase the status of the
successful university, and might (in some cases) impact directly or indirectly
on the economies of the local area, and thus state. Whether it is “worth it”
from a direct financial return-on-investment (ROI) point of view probably
depends upon the individual situation. It is almost never financially “worth
it” directly; universities (medical especially) almost always lose money on
their research endeavors even when you don’t factor in multi-million dollar
recruitment packages; most “wet-lab” (biomedical) research (as opposed to say,
community based or epidemiologic research) costs a lot more than even the sum of
the “direct” dollars from the National Institutes of Health (NIH) and the indirect dollars (often 50% or
more of the “direct”) that is supposed to help support the infrastructure. Add
in another $5, $10, $20, $40 million more and you have a really hard time
coming out anywhere close to break even.

But so what? The money for biomedical research has to come
from somewhere; the usual source is NIH, but if states want to sweeten that,
why not? After all, there are privately funded research institutes (the Stowers
Institute in Kansas City is a local example); why not state, as well as
federal. There are some concerns in that the federal (NIH) funds are the result
of a competitive peer-review process, while these state funds are often just
awarded to researchers based upon cachet. Still, if the state believes it has a
chance for direct or indirect economic benefit, maybe it should “go for it”.

The bigger issue is not whether biomedical research should
occur or who should support it, but why there should be competition for which
university or state gets the big researchers. Does this facilitate biomedical
researchers finding out more about how to treat or cure disease? I guess if
more money is available, more progress could be made. But the bidding wars
between universities and states seem to me to be more about local glory and (if
lucky) economic development than real advances in biomedical research. It is
similar to states and localities trying to lure employers by tax breaks, which
may sometimes cost more than the economic benefit. Or, in the case of the
Kansas City metropolitan area which straddles two states, luring companies back
and forth across the state line (so that employees don’t even have to move) in
what seems not-even-break-even mode (considering the cost of tax breaks). There
may sometimes be benefit to science or the public good from relocating
researchers and their laboratories but certainly not at the level and frequency
it is occurring, and not enough to justify the huge expenditures. Often there
is little or no new value being generated, but rather a shifting of resources
from one place to another, maybe with a little loss in the process. However,
this is how much of our economy works; the stock market and most of the
financial industry – moving money around, skimming off profit (HUGE profit –
the profiteers here are most of the richest of the billionaires) without
creating any real value for the society.

Even more important is the implication that this is
benefiting people’s health. If we wanted, as a society, to actually benefit
people’s health, there are a lot more direct, effective, cost-effective and
rational ways to do so. This, of course, could partly be providing financial
access to health care for everyone regardless of their socioeconomic or other
status, including those who have been left out of the ACA expansion because
they life in states that have not expanded Medicaid, because they are
undocumented, or because the level of health insurance that they can afford on
the exchanges doesn’t meet all their health needs. A single-payer health
system, Medicare for all. It also could mean enhancing geographic access, for
those who are in rural areas or underserved urban areas, by using whatever is
necessary (like financial incentives) to get doctors and hospitals to service
these communities. It could also mean increasing the number and percentages of
health care providers entering our most needed specialties, such as primary
care, either by direct subsidy or by stopping the skewed and counterproductive
reimbursement of subspecialists at much higher levels. (In Denmark, I
discovered, general practitioners usually earn more than subspecialists! It is all about policy, not about the
market.)

But, even more narrowly, talking about research, there is
the question of getting out the therapies that research has already shown work,
and are effective, and often cost-effective, to the people who need them.
Continuing to do more research and find out more things is great, but actually
having a national (or even state) system to ensure that the important
discoveries are disseminated and implemented, is a greater priority. There are
many common conditions, such as diabetes, for which we have treatments that are
simply not available to many people, for many of the reasons above. Some of the
unavailability of effective treatments are cost (the rapacious prices and
profits charged by drug companies), but there are also treatments that are
unavailable because – well, we don’t know why. While we continue to do more
research on discovery, we need to do even more on efficacy, and fidelity, and
finding out how to get our people to actually have improved health. Competition
for researchers without increasing value is as wrong as it is in any arena.

The most effective treatments need to be available to all,
the ineffective to none. We don’t need biomedical supremacy of Texas over New
York, or California universities over those in Massachusetts, or even in the US
over the rest of the world. We don’t need one university to “win” over another.
We need better health for all our people.

Sunday, September 6, 2015

Does prevention save money? That is, does increasing access
to preventive health care, doing more screening tests on a larger number of
people, end up saving more money in the long term by reducing the cost of
caring for the diseases that are prevented? This is the question asked in “Conventional
wisdom clashes with data on health care savings”, by Margot Sanger-Katz in
the New York Times on August 7, 2015.
Ultimately, she answers “no”; indeed, in the online version dated August 5 that
the link above takes you to, the article is titled “No, Giving More People Health Insurance Doesn’t
Save Money”. Although it of course depends upon which preventive test we
are talking about; “Counseling on contraception is one [of the preventive interventions that
actually do save money] because the costs
of prenatal care, delivery and pediatric care associated with an unplanned
pregnancy are so substantial. But a lot of the preventive health measures that
we tend to value a lot — mammography, screening for diabetes — tend to cost
more than they save.”

The motivation
for this article at this time is clearly the Affordable Care Act (ACA), which
not only resulted in more people receiving coverage but mandated that
preventive services be covered with no co-pay. President Obama made the case
for it in part by talking about cost savings; Sanger-Katz quotes his 2009
address to Congress: “There’s no reason
we shouldn’t be catching diseases like breast cancer and colon cancer before
they get worse. That makes sense, it saves money, and it saves lives.” But, in fact, the discussion on the cost vs
cost-saving from preventive services is not new; it has been frequently
addressed in the literature. I have written about it several times, including
two sequential posts on February 2 and February 9, 2009: Prevention
and Cost and Economics
and Disease Prevention, that cited two important articles on the topic, by
Russell in Health Affairs[1]and by Woolf in JAMA.[2]

Sanger-Katz also cites two studies to support the argument,
one old and one more recent. The famous RAND health insurance
experiment from the 1970s and 80s that examined the impact of providing
free (to the patient) access to health care, and the more recent Oregon health insurance experiment,
begun in 2008, where poor people who were not already on Medicaid were
lotteried into receiving health coverage or not. As she notes, in both studies,
people who got free or low-cost coverage used more care, and thus cost more
money. This, she notes, is consistent with basic economic theory, and ”…follows the pattern for nearly every other
good in the economy, including food, clothing and electronics. The cheaper they
are for people, the more they are likely to buy.”

But, while true, this misses the most important point. I
have written about both studies before, I discussed the RAND study in Insurance
company profits up and patient care down, May 11, 2011, and also refer to
it in my discussion of Oregon, The
Oregon Lottery: Far from enough, but at least they are doing something,
July 19, 2012. In the latter, I quote from a June 22, 2012 New York Times article by Annie Lowrey, “Oregon Study Shows
Benefits, and Price, for Newly Insured” that the study “has found that gaining insurance makes people feel healthier, happier
and more financially stable,” and that “The
insured were 25 percent less likely to have an unpaid medical bill sent to a
collection agency and 40 percent less likely to borrow money or skip paying
other bills in order to cover their medical costs.” This is the truly
important point; people are getting medical care that they need, and are not
having to cut back on their other basic needs (remember, these are poor people who don’t have lots of
discretionary income) to do so. It echoes the findings of RAND, which were
basically: yes, people who got free health care used more care, and indeed used
more care that experts considered “inappropriate” (the classic “going to the ER
for a cold” trope). But it also found that, and this is the real take-home
message, they used more appropriate care;
the corollary trope is going to the ER for chest pain, instead of staying home
and hoping it would go away because you’re afraid to incur the cost. Free
health care not only saved lives, it improved health.[3]

Ultimately, as Sanger-Katz points out, everyone dies. While
provision of preventive services may save lives from one disease “…every
time you prevent people from dying from one disease, they are likely to live
longer and incur future medical expenses. The patient who benefits from the
cholesterol screening may go on to develop cancer, arthritis, Alzheimer’s or
some other costly illness.” This may seem obvious, but only if you think about it. In the 1980s, I was
the only physician student in a class on Health Administration; the other
students were planning on being health administrators but did not have a
medical background. In one class, a student reported that we were likely to
save money in the future because people were adopting healthier lifestyles –
eating better, exercising more, not smoking as much. I pointed out that the
opposite was true; this would mean people lived longer, and were more likely to
develop long-term chronic diseases leading them to, for example, long
hospitalizations and nursing home stays. If you truly wanted to save money,
you’d encourage a high-cholesterol diet, no exercise, and 2 packs of cigarettes
a day, so everyone would drop dead from a heart attack in their late 40s and be
done with the cost.

This may sound macabre, but the point it makes is that cost
is not the only issue. Examining the cost of providing free health care, as in
RAND 40 years ago, or free preventive care, as in ACA, is a legitimate
activity, but it is not the only, or even most important outcome. Access to
health care, prevention of premature death, and improvement in quality of life
are also critical considerations. Cost is important, but cost control cannot be
measured in such crude ways as “does prevention save money”? First, as
Sanger-Katz noted, different preventive services have stronger evidence behind
them, and have a smaller “number needed to treat” (NNT) to have an impact on
either cost or lives saved or quality of life (thus a high priority should be
expanding access to contraception and contraceptive counseling). Second, there
is the expansion of indications (reasons for doing a test), either through
providing preventive services to a larger group of people than those shown to
have the most benefit in studies, or by ratcheting down the “goal” for things
like cholesterol, blood pressure, or blood sugar. These both have the same
effect; they decreases the average long-term benefit while increasing the cost
(and, not coincidentally, the profits for the manufacturers of the drugs and
purveyors of the tests).

Third, and by far the most important in terms of both cost
and justice, is the application of different standards to different
populations, based on insurance status, wealth, and race. Performing preventive
services for people who are unlikely to benefit is a problem, but performing
much more expensive interventions for people who almost certainly won’t benefit
just because they want them, and they (or their insurer) can pay for them, and
because the providers doing them make money, is a far greater issue for cost.
In addition, there is the question of “what is a fair price?” for any service,
preventive or therapeutic, indicated or not (well, if not indicated, the fair
price is zero!). In The
high cost of US health care: it's not the colonoscopies, it's the profit,
Jul 28 2013, I cited the work of Elisabeth Rosenthal of the New York Times, on this topic; she
presents the wide variation in costs for this and other procedures. Thinking of
the myriad types of preventive interventions as if they were all the same and
of the same value is like thinking of “cancer” as one disease, rather than
hundreds; it is simple and it is incorrect.

Ultimately, the cost issue is addressed by equity. Everyone
should have access to all interventions that are likely to help them, and no
one to those that will not.